FDA 510(k) Application Details - K203771

Device Classification Name	Urease And Glutamic Dehydrogenase, Urea Nitrogen   More FDA Info for this Device
510(K) Number	K203771
Device Name	Urease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant	Abbott Ireland Diagnostics Division Lisnamuch Longford IE Other 510(k) Applications for this Company
Contact	Tiffini Jenkins Other 510(k) Applications for this Contact
Regulation Number	862.1770   More FDA Info for this Regulation Number
Classification Product Code	CDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2020
Decision Date	05/31/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review